Multicenter expanded access program for access to investigational products for amyotrophic lateral sclerosis.

INTRODUCTION/AIMS: Expanded access (EA) is a Food and Drug Administration-regulated pathway to provide access to investigational products (IPs) to individuals with serious diseases who are ineligible for clinical trials. The aim of this report is to share the design and operations of a multicenter, multidrug EA program for amyotrophic lateral sclerosis (ALS) across nine US centers. METHODS: A central coordination center was established to design and conduct the program. Templated documents and processes were developed to streamline study design, regulatory submissions, and clinical operations across protocols. The program included three protocols and provided access to IPs that were being tested in respective regimens of the HEALEY ALS Platform Trial (verdiperstat, CNM-Au8, and pridopidine). Clinical and safety data were collected in all EA protocols (EAPs). The program cohorts comprised participants who were not eligible for the platform trial, including participants at advanced stages of disease progression and with long disease duration. RESULTS: A total of 85 participants were screened across the 3 EAPs from July 2021 to September 2022. The screen failure rate was 3.5%. Enrollment for the regimens of the platform trial was completed as planned and results informed the duration of the corresponding EAP. The verdiperstat EAP was concluded in December 2022. Mean duration of participation in the verdiperstat EAP was 5.8 ± 4.1 months. The CNM-Au8 and pridopidine EAPs are ongoing. DISCUSSION: Multicenter EAPs conducted in parallel to randomized clinical trials for ALS can successfully enroll participants who do not qualify for clinical trials.

Bhutanese Refugee Youth: The Importance of Assessing and Addressing Psychosocial Needs in a School Setting.

BACKGROUND: Traumatic exposure combined with significant stressors in resettlement place Bhutanese refugees at risk for mental health problems. Despite this, refugee youth often are reluctant to seek mental health services. Psychosocial support services, such as school-based groups, offer one solution to this barrier to care. We had 2 aims in this study: (1) to describe the psychosocial needs of resettled Bhutanese refugee students; and (2) to evaluate the impact of skills-based groups on these students' sense of school belonging and mental health. METHODS: Bhutanese refugee students in middle school (N = 34) participated in the 12-week group curriculum (a component of Trauma Systems Therapy for Refugees) and the associated preevaluation/postevaluation. RESULTS: Baseline descriptive analyses indicated high levels of mental health symptoms; approximately, 49% of students met partial or full criteria for posttraumatic stress disorder. In addition, sense of school belonging was significantly inversely associated with depressive and posttraumatic stress symptoms at baseline. Paired sample t tests indicate that students' avoidance symptoms significantly decreased postintervention. CONCLUSIONS: Findings suggest that skills-based groups may be an effective way to engage students in supportive services and address psychosocial needs. Results further highlight the potential protective role of school belonging in reducing refugee students' vulnerability to psychological distress.

Making a Footprint in Environmental Sustainability: A Behavioral Systems Approach to Engaging the Behavioral Community.

Climate change is arguably the most pressing issue facing humanity today. There is significant research to support the argument that climate change is a human-created problem and it can only be addressed by changing human behavior. Despite the magnitude of the issue and the potential for behavior science to make a significant contribution, there are few behavior analysts/scientists currently working in climate change. One possible explanation is that there is limited access to preparation for and opportunities to apply our science to large-scale issues. In response, the Behaviorists for Social Responsibility Special Interest Group of the Association for Behavior Analysis International developed the Matrix Project as a way to apply Behavioral Systems Analysis to issues of social importance. By understanding the contingencies that hinder or promote working in a particular area we can begin to create the conditions that will facilitate such work. The purpose of this article is twofold: 1) to demonstrate how the Matrix Project may be used to increase the likelihood that behavior analysts/scientists will work in areas of social importance using environmental sustainability as an example, and 2) encourage behavior analysts/scientists to target and understand complex systems by providing examples of actionable steps that could be generalized to other important social issues.

Predicting adolescent posttraumatic stress in the aftermath of war: differential effects of coping strategies across trauma reminder, loss reminder, and family conflict domains.

BACKGROUND AND OBJECTIVES: The vast majority of youth who lived through the Bosnian war were exposed to multiple traumatic events, including interpersonal violence, community destruction, and the loss of a loved one. This study examined factors that predict post-war psychological adjustment, specifically posttraumatic stress, in Bosnian adolescents. DESIGN: Regression analyses evaluated theorized differential relations between three types of post-war stressors - exposure to trauma reminders, loss reminders, and intrafamilial conflict - specific coping strategies, and posttraumatic stress symptom dimensions. METHODS: We examined 555 Bosnian adolescents, aged 15-19 years, to predict their long-term posttraumatic stress reactions in the aftermath of war. RESULTS: Findings indicated that post-war exposure to trauma reminders, loss reminders, and family conflict, as well as engagement and disengagement coping strategies, predicted posttraumatic stress symptoms. Secondary control engagement coping responses to all three types of post-war stressors were inversely associated with posttraumatic stress symptoms, whereas primary control engagement coping responses to family conflict were inversely associated with hyperarousal symptoms. Disengagement responses to trauma reminders and family conflict were positively associated with re-experiencing symptoms. CONCLUSIONS: These findings shed light on ways in which trauma reminders, loss reminders, and family conflict may intersect with coping responses to influence adolescent postwar adjustment.

Understanding Bhutanese refugee suicide through the interpersonal-psychological theory of suicidal behavior.

Attention has been drawn to high rates of suicide among refugees after resettlement and in particular among the Bhutanese refugees. This study sought to understand the apparent high rates of suicide among resettled Bhutanese refugees in the context of the Interpersonal-Psychological Theory of Suicidal Behavior (IPTS). Expanding on a larger investigation of suicide in a randomly selected sample of Bhutanese men and women resettled in Arizona, Georgia, New York, and Texas (Ao et al., 2012), the current study focused on 2 factors, thwarted belongingness and perceived burdensomeness, examined individual and postmigration variables associated with these factors, and explored how they differed by gender. Overall, factors such as poor health were associated with perceived burdensomeness and thwarted belongingness. For men, stressors related to employment and providing for their families were related to feeling burdensome and/or alienated from family and friends, whereas for women, stressors such as illiteracy, family conflict, and being separated from family members were more associated. IPTS holds promise in understanding suicide in the resettled Bhutanese community.

Mental health service utilization of Somali adolescents: religion, community, and school as gateways to healing.

This mixed-method study examines the utility of the Gateway Provider Model (GPM) in understanding service utilization and pathways to help for Somali refugee adolescents. Somali adolescents living in the Northeastern United States, and their caregivers, were interviewed. Results revealed low rates of use of mental health services. However other sources of help, such as religious and school personnel, were accessed more frequently. The GPM provides a helpful model for understanding refugee youth access to services, and an elaborated model is presented showing how existing pathways to help could be built upon to improve refugee youth access to services.

Cross-situational coping with peer and family stressors in adolescent offspring of depressed parents.

Offspring of depressed parents are faced with significant interpersonal stress both within their families and in peer relationships. The present study examined parent and self-reports of adolescents' coping in response to family and peer stressors in 73 adolescent children of parents with a history of depression. Correlational analyses indicated that adolescents were moderately consistent in the coping strategies used with peer stress and family stress. Mean levels of coping were similar across situations, as adolescents reported greater use of secondary control coping (i.e., acceptance, distraction) than primary control coping (i.e., problem solving, emotional expression) or disengagement coping (i.e., avoidance) with both types of stress. Regression analyses indicated that fewer symptoms of self-reported anxiety/depression and aggression were related to using secondary control coping strategies in response to family stress and primary control coping in response to peer stress. Implications for understanding the characteristics of effective coping with stress related to living with a depressed parent are highlighted.

Coping with the stress of parental depression II: adolescent and parent reports of coping and adjustment.

This study examined associations between adolescents' self-reports and parents' reports of adolescents' exposure to family stress, coping, and symptoms of anxiety/depression and aggression in a sample of 78 adolescent offspring of depressed parents. Significant cross-informant correlations were found between adolescents' reports of family stress, their stress responses, and their coping and parents' reports of adolescents' symptoms of anxiety/depression and aggression, but not between parents' reports of adolescents' stress and coping and adolescents' self-reported symptoms. Adolescents' reports of secondary control engagement coping and involuntary engagement stress responses mediated the relation between adolescents' reports of parental stress and parents' reports of adolescents' anxiety/depression symptoms. Moderate levels of correspondence were found in the correlations between parent and adolescent reports of adolescents' exposure to stress, coping, stress responses, and symptoms even after controlling for parents' current depressive symptoms. However, depressed parents reported higher levels of symptoms of anxiety/depression and aggression and more family stress than did their adolescent offspring. Implications for future research on coping and adjustment in offspring of depressed parents are highlighted.